(31 days)
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
The provided document describes the DIASCREEN® Reagent Strip System, focusing on the new leukocyte reagent area. The study aims to demonstrate substantial equivalence to previously approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are based on a clinical correlation study comparing the DIASCREEN® Leukocyte Reagent Strips to the Bayer Multistix 10 SG. The performance is reported as the percentage of responses falling within the same color block and within plus or minus one color block compared to the predicate device.
| Test Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (DIASCREEN® vs. Bayer Multistix) |
|---|---|---|
| Leukocyte Test - Same Color Block | High percentage agreement with predicate device desirable for substantial equivalence. | Evaluation One - Lot 1: 90% (35/39) Evaluation One - Lot 2: 90% (35/39) Evaluation Two: 85% (237/279) |
| Leukocyte Test - Within ±1 Color Block | Very high percentage agreement with predicate device (e.g., >95% to ensure clinical utility). | Evaluation One - Lot 1: 100% (39/39) Evaluation One - Lot 2: 100% (39/39) Evaluation Two: 96% (268/279) |
Note: The document implies "substantial equivalence" as the primary acceptance criterion, rather than specific numerical cutoffs. The reported performance demonstrates a strong agreement with the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Leucocyte Test (Comparison to Bayer Multistix):
- Evaluation One: 39 fresh urine samples (for each of the two DIASCREEN® lots tested).
- Evaluation Two: 279 fresh urine samples.
- Data Provenance: Prospective. Fresh urine samples were obtained at a medical facility for Evaluation One and at two clinical sites for Evaluation Two. The origin country is not explicitly stated, but the contact person and institutions (Wichita State University, Technovations Inc.) suggest the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was established by the results obtained from the "510(k) approved" marketed urinalysis strip system, specifically the Bayer Multistix 10 SG Reagent Strips. The readings of the DIASCREEN® strips were then visually compared to the DIASCREEN® color chart, which would presumably be interpreted by trained laboratory personnel.
- No specific "experts" were used to establish a separate ground truth. Instead, the predicate device (Bayer Multistix 10 SG) acted as the reference standard.
- For Evaluation One, the study was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. This individual possesses medical technology qualifications.
- For Evaluation Two, the study was conducted under the direction of Myron Rapkin, Technovations Inc. No specific qualifications are listed for this individual in the provided text.
4. Adjudication Method for the Test Set
The adjudication method was a direct comparison between the visual readings of the DIASCREEN® Reagent Strips using their own color chart and the results from the Bayer Multistix 10 SG Reagent Strips. There is no mention of an independent adjudication panel or consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual, visual dip-and-read test strip, not an AI-assisted system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm-only performance study was not done. The device is a visual dip-and-read test strip that requires human interpretation of color changes against a color chart.
7. The Type of Ground Truth Used
The ground truth used was the performance of a legally marketed and "510(k) approved" predicate device: the Bayer Multistix 10 SG Reagent Strips. This is a form of comparative ground truth against another validated diagnostic method rather than an absolute "expert consensus," "pathology," or "outcomes data" ground truth for the condition itself.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or "validation set" in the context of the clinical evaluation. The reported evaluations appear to be performance studies for verification rather than training a machine learning model. The strips were developed using established chemical reagents and principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a discrete training set with explicitly established ground truth (in the AI context) is not described for this type of medical device submission. The device design and reagent compositions were likely developed based on known chemical reactions and prior experience with similar urinalysis strips.
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Ka81555J
Summary of Safety and Effectiveness
April 22, 1998
The following information is provided as a summary of safety and effectiveness information for the DIASCREEN® Reagent Strip System. The reagent strips which are the subject of this pre-market notification contain one new reagent area for leukocytes in urine. The other nine reagent areas have been previously reviewed.
-
Common Name: Visual Reagent Test Strip for Urinalysis (al
Trade/Proprietary Name: DIASCREEN® Reagent Strips, in many different configurations with as many different product codes. DIASCREEN® the registered trademark of Dia-Screen is Corporation. -
[b] Establishment Registration Number: 2183670
Chronimed Inc. Bury Drive Eden Prairie, MN 55346 -
Contact Person: lcl
Vicki Frawley 5182 West 76th Street Minneapolis. MN 55439 Phone: (612) 835-3446 ext. 17 Fax: (612) 835-9406 -
[d] Intended Use
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.
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Product Description lel
DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.
The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.
The directions must be followed exactly. Accurate timing is essential to provide optimal results. The reagent strips must be kept in the original bottle containing the desiccant with the cap tightly closed to maintain reagent activity. To obtain optimal results it is necessary to use fresh, well-mixed, uncentrifuged urine.
Corporation has previously received Dia-Screen determination of substantial equivalence for complete lines of reagent strips for urinalysis which have been marketed under the Bioscan label (K940043) and the DIASCREEN® label (K952971. K961375). The intended use of the strips that are the subject of this new premarket notification is exactly the same as the Bioscan (K940043) and DIASCREEN® (K952971, K961375) strips which were reviewed previously.
Chronimed Inc. purchased Dia-Screen Corporation on March The DIASCREEN® Reagent Strips will 16. 1998. be manufactured by Chronimed Inc. for distribution by Chronimed Inc.
[f] Substantial Equivalence
The intended use of the strips which are the subject of this new pre-market notification is exactly the same as the strips which were reviewed previously (K940043, K943008, K952971, K961375. K971976).
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The design and function of the new DIASCREEN® Reagent Strips are the same as the design and function of both the Bioscan and DIASCREEN® Reagent Strips which have been previously reviewed under pre-market notifications K940043, K943008, K952971, K961375, and K971976.
Ship ... ..
The DIASCREEN® Reagent Strips for Urinalysis are substantially equivalent to the previous line of DIASCREEN® Reagent Strips (K943008, K961375) and the Bayer Multistix 10 SG Reagent Strips for Urinalysis. The new reagent area for leukocytes in urine on the DIASCREEN® Reagent Strips is substantially equivalent to the reagent area for leukocytes in urine on the Bayer Multistix 10 SG reagent strips.
Characteristics of the Bayer Multistix 10 SG system and the previous DIASCREEN® system are compared with the subject DIASCREEN® system in the following table.
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| Strip NameDistributor | This 510 (k)DIASCREEN®Dia-Screen | Prevoius 510 (k)DIASCREEN®Dia-Screen | Bayer Multistix 10 SGBayer |
|---|---|---|---|
| Reagents for: | |||
| Leukocyte | 2-(3-Methoxyphenyl)-4-thiazolDiazonium salt | Not offered | Derivatized pyrrole aminoacid esterDiazonium saltBuffer |
| SpecificGravity | Bromothymol blueMethyl redPolyvinyl phosphate | Bromthymol blueDetergent | Bromthymol bluePoly (methyl vinyl-ethermaleic anhydride) |
| Ketones | Sodium nitroprusside | Sodium nitroprusside | Sodium nitroprussideBuffer |
| Glucose | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodide | Glucose oxidasePeroxidasePotassium iodideBuffer |
| Protein | Tetrabromphenol blueCitric acidTrisodium citrate | Tetrabromphenol blueCitric acidTrisodium citrate | Tetrabromphenol blueBuffer |
| Blood | 2,5 Dimethylhexane-2,5-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | 2,5 Dimethylhexane-2,5-dihydroperoxide3,3',5,5'-Tetramethylbenzidine | Diisopropylbenzene-dihydroperoxide3,3',5,5'-Tetramethylbenzidine |
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| This 510 (k) | Prevoius 510 (k) | ||
|---|---|---|---|
| Strip Name | DIASCREEN® | DIASCREEN® | Bayer Multistix 10 SG |
| Distributor | Dia-Screen | Dia-Screen | Bayer |
| Reagents for: | |||
| Nitrite | p-Arsanilic acidHydroxy(3)-1,2,3-tetrahydrobenzo(h)quinoline | p-Arsanilic acidHydroxy(3)-1,2,3-tetrahydrobenzo(h)quinoline | p-Arsanilic acid1,2,3,4-Tetrahydro-benzo(h)quinoline-3-olBuffer |
| pH | Bromthymol blueMethyl red | Bromthymol blueMethyl red | Bromthymol blueMethyl red |
| Bilirubin | 2,4 Dichlorobenzene-diazonium saltSulfasalicylic acid | 2,4 Dichlorobenzene-diazonium salt | 2,4-Dichloroaniline-diazonium saltBuffer |
| Urobilinogen | 4-methoxybenzene-diazonium saltMetaphosphoric acid | Dimethylaminobenzaldede | Diethylaminobenzaldede |
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| Strip NameDistributor | This 510 (k)DIA SCREEN®Dia-Screen | Previous 510 (k)DIA SCREEN®Dia-Screen | Multistix 10 SGBayer |
|---|---|---|---|
| Packaged withDesiccant | Yes | Yes | Yes |
| Control Available | Yes | Yes | Yes |
| Time required toread strips | 30 to 120 seconds | 30-60 seconds | 30 to 120 seconds |
| Storage | Between 15 - 30 °C (59°-86° F). Do Not Store inrefrigerator or freezer. Donot expose to moisture,heat or light. | Between 15 - 30 °C (59°-86° F). Do Not Store inrefrigerator or freezer. Donot expose to moisture,heat or light | Between 15°-30° C (59°-86° F) Do Not Store inDirect Sunlight |
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| Strip NameDistributor | This 510 (k)DIA SCREEN®Dia-Screen | Previous 510 (k)DIA SCREEN®Dia-Screen | Multistix 10 SGBayer |
|---|---|---|---|
| Expected Values: | |||
| Leukocyte | Normally no leukocytesare detected in urine.Individually observedtrace results may be ofquestionable clinicalsignificance. Positiveresults found in randomspecimens from femalesmay be due to vaginalcontamination. | Not applicable. | Normal urine specimensgenerally yield negativeresults. Positive results(small or greater) areclinically significant.However, trace resultsobserved repeatedly maybe clinically significant/Positive and repeatedtrace results indicate theneed for testing of thepatient and/or urinespecimen according tomedically acceptedprocedures for pyuria.Positive results may befound with randomspecimens from femalesdue to contamination byvaginal discharge |
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| Strip Name | This 510 (k)DIA SCREEN® | Previous 510 (k)DIA SCREEN® | Multistix 10 SGBayer |
|---|---|---|---|
| DistributorExpected Values: | Dia-Screen | Dia-Screen | Bayer |
| Leukocyte | Normally no leukocytesare detected in urine.Individually observedtrace results may be ofquestionable clinicalsignificance. Positiveresults found in randomspecimens from femalesmay be due to vaginalcontamination. | Not applicable. | Normal urine specimensgenerally yield negativeresults. Positive results(small or greater) areclinically significant.However, trace resultsobserved repeatedly maybe clinically significant/Positive and repeatedtrace results indicate theneed for testing of thepatient and/or urinespecimen according tomedically acceptedprocedures for pyuria.Positive results may befound with randomspecimens from femalesdue to contamination byvaginal discharge. |
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SS and E Page 8
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| Strip NameDistributorExpected Values: | This 510 (k)DIA SCREEN®Dia-Screen | Previous 510 (k)DIA SCREEN®Dia-Screen | Multistix 10 SGBayer |
|---|---|---|---|
| Specific Gravity | Random urines vary from | Random urines vary from | Random urines vary from |
| 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four | 1.001-1.035. Twenty-four | |
| hour urines from normal | hour urines from normal | hour urines from normal | |
| adults with normal diets | adults with normal diets | adults with normal diets | |
| and fluid intake will have | and fluid intake will have | and fluid intake will have | |
| a specific gravity of | a specific gravity of | a specific gravity of | |
| 1.016-1.022 | 1.016-1.022 | 1.016-1.022 | |
| Ketones | Should not be detected in | Should not be detected in | Normal specimens yield |
| normal urine. | normal urine. | negative results. | |
| Glucose | None found in normal | None found in normal | None found in normal |
| urine. Concentrations of | urine. Concentrations of | urine. Concentration of | |
| 100 mg/dL may be | 100 mg/dL may be | 100 mg/dL may be | |
| considered abnormal. | considered abnormal. | considered abnormal. | |
| Protein | Normal specimens | Normal specimens | Normal specimens |
| ordinarily contain some | ordinarily contain some | ordinarily contain some | |
| protein (0-4 mg/dL). | protein (0-4 mg/dL). | protein (0-4 mg/dL). A | |
| Persistent results of trace | Persistent results of trace | color matching any "+" | |
| or higher indicate | or higher indicate | block indicates significant | |
| significant proteinuria. | significant proteinuria. | proteinuria |
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Clinical Laboratory Evaluation of DIASCREEN® Strips
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip intended for use as an in-vitro diagnostic aid using urine specimens. DIASCREEN® Reagent Strips have been developed to allow health care professionals to semi-quantitatively determine levels of specific gravity, leukocyte, ketone, glucose, protein, blood, nitrite, pH, bilirubin, and urobilinogen in patient urine by visual comparison with a color chart of each concentration range. No additional reagents or laboratory equipment are required. These reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be maintained tightly capped in the plastic vial to assure reagent activity. The directions-for-use must be followed exactly.
Two independent laboratory evaluations of the DIASCREEN® Urine Leukocyte Test were conducted. The purpose of the laboratory evaluations was to establish the performance of the leukocyte test when compared to a "510(k) approved" marketed urinalysis strip system.
Clinical Evaluation One was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology (Site 1). The study consisted of comparing the performance of two (2) manufactured lots of DIASCREEN® Leukocyte Reagent Strips with the marketed product (Baver Multistix 10 SG).
Fresh urine samples were obtained at the medical facility. The comparison strips, Bayer Multistix 10 SG Reagent Strips, were furnished by Dia-Screen.
Fresh, well-mixed, and uncentrifuged urine from a mixed patient population was reacted with the DIASCREEN® Reagent Strips and the results were read by visual comparison with the DIASCREEN® color chart. Results of these readings were compared to results measured by Multistix 10 SG Reagent Strips.
Clinical Evaluation Two was conducted under the direction of Mvron Rapkin. Technovations Inc. at two clinical sites. Reagent strips and urine samples were handled as described above.
A summary of the data obtained from the two clinical evaluations follows. Table I presents the percentage of responses of the DIASCREEN® Strips that are within the same color block and that are within plus or minus one color block of Baver Leukocyte results. Table II presents a similar analysis for two lots of the DIASCREEN® Reagent Strips tested during Clinical Evaluation One. The data used to compile these tables is presented for each evaluation in charts where the shaded region represents the within plus or minus one color block range.
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DIASCREEN® versus Bayer Clinical Correlation
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DIASCREEN® Lot 1 versus Bayer Multistix Table I.
| Same Color Block | Within 1 Color Block | |||
|---|---|---|---|---|
| Evaluation One-Lot 1 | 35/39 | 90% | 39/39 | 100% |
| Evaluation One-Lot 2 | 35/39 | 90% | 39/39 | 100% |
| Evaluation Two | 237/279 | 85% | 268/279 | 96% |
DIASCREEN® Lot 1 versus DIASCREEN® Lot 2 Table II.
| ----------Evaluation One- | Same Color Block | Within 1Color Block | ||
|---|---|---|---|---|
| ofLOT /check of the consistence and a commended in the consistent of the comments of the comments of | 35/39of Acres of Children Company of Children Company of Children Company of Children Company of Children Company of Children Company of Children | 97%of the property of the produced the program and the county of | 39/39 | 100%Company of Canadian Call Property of Children Company of Children |
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Page_1 of 1
510(k) Number (if known); $69 x 155
Device Name: DIASCREEN Reagent Strips
Indications For Use:
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The
test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use______ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---|---|
| --------------- | --------- |
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NT OF HEALT
Image /page/12/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
JUN 11 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Vicki Frawley . Chronimed Inc. 5182 West 76th Street Minneapolis, Minnesota ਦੇ ਦੇ ਤੇ ਰ
Re: K981555 DIASCREEN® Leukocyte Reagent Strip for Urinalysis Requlatory Class: II Product Code: LJX Dated: April 22, 1998 Received: May 1, 1998
Dear Ms. Frawley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page == 1 = of i
510(k) Number (if known); 40 9 3 15 55
Device Name: DIASCREEN Reagent Strips
Indications For Use:
The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.
The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The
test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | ✓ |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981555 |
|---|---|
| --------------- | --------- |
§ 864.7675 Leukocyte peroxidase test.
(a)
Identification. A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.(b)
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.